FDA 510(k) Applications for Medical Device Product Code "KWI"
(Prosthesis, Elbow, Hemi-, Radial, Polymer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K041858 | ACUMED LLC | ACUMED ANATOMIC RADIAL HEAD SYSTEM | 10/05/2004 |
| K131845 | ACUMED LLC | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | 09/30/2013 |
| K032686 | ASCENSION ORTHOPEDICS, INC. | ASCENSION MODULAR RADIAL HEAD | 10/22/2003 |
| K023604 | AVANTA ORTHOPAEDICS, INC. | MODIFICATION TO RADIAL HEAD IMPLANT | 11/27/2002 |
| K002644 | AVANTA ORTHOPAEDICS, INC. | RADIAL HEAD IMPLANT | 11/20/2000 |
| K011819 | AVANTA ORTHOPAEDICS, INC. | RADIAL HEAD IMPLANT | 06/19/2001 |
| K982288 | AVANTA ORTHOPAEDICS, INC. | RADIAL HEAD IMPLANT | 09/08/1998 |
| K051385 | BIOMET, INC. | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | 08/05/2005 |
| K012551 | BIOMET, INC. | LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE | 01/30/2002 |
| K040611 | BIOMET, INC. | MODULAR RADIAL HEAD REPLACEMENT DEVICE | 06/04/2004 |
| K000658 | DEPUY ORTHOPAEDICS, INC. | ERS RADIAL HEAD REPLACEMENT | 05/11/2000 |
| K213563 | DePuy Synthes | DePuy Synthes Radial Head Replacement System | 03/18/2022 |
| K001385 | HOWMEDICA OSTEONICS CORP. | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS | 07/27/2000 |
| K183618 | Ignite Orthopedics, Inc. | Revolution Radial Head | 05/17/2019 |
| K132735 | IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME | AXIA RADIAL HEAD SYSTEM | 01/07/2014 |
| K984290 | IMPLEX CORP. | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM | 06/01/1999 |
| K192754 | In2Bones USA, LLC | Avenger Radial Head System | 01/07/2020 |
| K212872 | In2Bones USA, LLC | Avenger Radial Head System | 12/17/2021 |
| K030237 | KAPP SURGICAL INSTRUMENT, INC. | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | 08/29/2003 |
| K032806 | KINETIKOS MEDICAL, INC. | KATALYST RADIAL HEAD IMPLANT | 04/16/2004 |
| K231188 | Skeletal Dynamics Inc | ALIGN Radial Head System | 09/28/2023 |
| K092721 | SKELETAL DYNAMICS, LLC | ALIGN RADIAL HEAD SYSTEM | 08/03/2010 |
| K172688 | Skeletal Dynamics, LLC | Align Radial Head System | 12/22/2017 |
| K062898 | SMALL BONE INNOVATIONS INC. | SBI LATERAL RHEAD IMPLANT | 11/13/2006 |
| K992220 | SMITH & NEPHEW, INC. | RADIAL HEAD PROSTHESIS | 02/25/2000 |
| K112030 | SYNTHES USA, LLC | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | 06/19/2012 |
| K994041 | TORNIER, INC. | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS | 08/31/2000 |
| K030384 | WRIGHT MEDICAL TECHNOLOGY, INC. | EVOLVE CERAMIC RADIAL HEAD IMPLANT | 08/12/2003 |
| K060731 | WRIGHT MEDICAL TECHNOLOGY, INC. | EVOLVE MODULAR RADIAL HEAD | 04/19/2006 |
| K991915 | WRIGHT MEDICAL TECHNOLOGY, INC. | MODULAR RADIAL HEAD | 09/03/1999 |
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